Single-Inhaler Maintenance AND Reliever Therapy for Asthma Control: A Primer for Pharmacists

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1 A FREE CONTINUING EDUCATION LESSON OBJECTIVES Upon successful completion of this lesson, the pharmacist will be able to: 1. assess asthma control and asthma severity in patients with asthma 2. discuss the principles of current Canadian asthma management guidelines and the continuum of asthma care 3. discuss evidence and scientific rationale supporting addition of a long-acting β2-agonist (LABA) to an inhaled corticosteroid (ICS) versus increasing dose of ICS in patients not controlled on low-dose ICS alone 4. compare and contrast the properties and roles in asthma therapy of the two currently available LABAs, formoterol and salmeterol 5. discuss evidence associated with the benefit of using a single inhaler containing budesonide and formoterol for both maintenance and relief of asthma compared with traditional protocols 6. educate and counsel patients on appropriate use of budesonide and formoterol as singleinhaler maintenance and reliever therapy when this therapy is approved in Canada. INSTRUCTIONS 1. After carefully reading this lesson, study each question and select the one answer you believe to be correct. Circle the appropriate letter on the attached reply card. 2. To pass this lesson, a grade of 70% (14 out of 20) is required. If you pass, your CEU(s) will be recorded with the relevant provincial authority(ies). (Note: some provinces require individual pharmacists to notify them.) ANSWERING OPTIONS A. For immediate results, answer online at B. Mail or fax the printed answer card to (416) Your reply card will be marked and you will be advised of your results within six to eight weeks in a letter from Rogers Publishing. THIS FREE LESSON IS APPROVED FOR 1.5 CE UNITS Approved for 1.5 CE units by the Canadian Council on Continuing Education in Pharmacy. File # Not valid for CE credits after August 25, Single-Inhaler Maintenance AND Reliever Therapy for Asthma Control: A Primer for Pharmacists By Tom Smiley, BSc Phm, Pharm D Tom Smiley is a pharmacist consultant and a community pharmacist in Brantford, Ont. In addition to his clinical experience with patients over the past 25 years, Tom has developed and presented many accredited CE lessons and workshops for pharmacists on the topic of asthma and allergic rhinitis. He has also written many patient brochures and web postings on this topic. Tom has personal experience as well, as he has been afflicted with allergies and asthma for most of his life. Tom currently sits on the Ontario Pharmacists Association board of directors and on the Family Health Team Action Group as appointed by the Ontario Ministry of Health. Expert reviewer Stacey Shipton and Pharmacy Practice magazine have each declared that there is no real or potential conflict of interest with the sponsor of this lesson. Author Tom Smiley discloses that he is a paid speaker for the sponsor of this lesson. Expert reviewer Antony Gagnon discloses that he has an unrestricted educational grant from GlaxoSmithKline INTRODUCTION Meet Kyle It s a Saturday afternoon, and your patient Kyle, an 18-year-old university student walks into your pharmacy for a refill of his salbutamol inhaler. You look at his profile and see that he has 3 refills left and he last received his inhaler 4 weeks ago to the day. You don t really take too much notice of the time interval because many of your patients have their reliever bronchodilators refilled at about 4- to 6-week intervals. He also has a prescription for budesonide inhaler 200 µg, 2 inhalations twice daily on his file. According to Canadian Asthma guidelines, a patient whose asthma is under control should require 3 or less doses (i.e., 6 or fewer inhalations) of reliever bronchodilator such as salbutamol or terbutaline weekly. 1 Patients are also allowed one dose of bronchodilator before exercise daily. Since each canister contains approximately 200 inhalations of medication, patients who have their asthma under control and use the maximum inhalations before exercise on a daily basis should require a refill of their reliever bronchodilator only once every 10 weeks. Patients who do not use their inhaler pre-exercise would require a refill once every 30 weeks. In a Canadian study that surveyed 829 men and women with asthma, 52% used their inhaled β2-agonist on a daily basis. 2 The scenario offered above occurs regularly in Canadian pharmacies. Clearly, we could be doing a much better job in helping our patients improve their quality of life through patient education, interdisciplinary collaboration and recommendations for better asthma control that keep pace with current evidence. Recently, a combination SUPPORTED BY AN EDUCATIONAL GRANT FROM October 2006 Answer online at Single-Inhaler Maintenance AND Reliever Therapy for Asthma Control: A Primer for Pharmacists 1

2 inhaler containing budesonide and formoterol used as single-inhaler therapy for both maintenance and relief of asthma symptoms has been shown to prolong time to first severe asthma exacerbation, reduce frequency of asthma exacerbations and improve asthma symptoms compared with traditional treatment protocols that utilize short-acting β2-agonists for relief. 3 The goal of this continuing education lesson is to refresh pharmacists knowledge about goals and guidelines of asthma therapy and to introduce them to evidence suggesting potential for improved asthma control with the utilization of one inhaler for both maintenance and relief of asthma symptoms. Note: Budesonide/formoterol has not yet received approval for the Single-Inhaler Maintenance and Reliever Therapy (SMART) indication within Canada. ASTHMA A WORKING DEFINITION The definition of asthma is largely descriptive. 4 The Global Initiative for Asthma (GINA) Guidelines recommend the following assessments when an asthma diagnosis is being considered: 4 Presence of wheezing - high-pitched whistling sounds when breathing out - especially in children. Normal chest examinations do not exclude asthma. History of any of the following: - Cough, worse particularly at night - Recurrent wheeze - Recurrent difficult breathing - Recurrent chest tightness Symptoms that occur or worsen at night, and awaken the patient Symptoms that occur or worsen in the presence of: - Animals with fur - Aerosol chemicals - Changes in temperature - Domestic dust mites - Certain drugs (e.g., ASA, beta blockers) - Exercise - Pollen - Respiratory (viral) infections - Smoke - Strong emotional expression Reversible and variable airflow limitation as measured by using a spirometer or a peak expiratory flow (PEF) meter. When using a peak flow meter consider asthma if: - PEF increases more than 15%, minutes after inhalation of a rapidacting β2-agonist, or - PEF varies more than 20% from morning measurement upon arising to measurement 12 hours later in patients taking a bronchodilator (more than 10% in patients who are not taking a bronchodilator), or - PEF decreases more than 15% after 6 minutes of sustained running or exercise. DEFINING ASTHMA CONTROL The Adult Asthma Consensus Guidelines Update 2003 offers the following as criteria for the control of asthma: 1 Daytime symptoms less than 4 days per week Night-time symptoms less than one night per week Normal physical activity Mild, infrequent exacerbations No absenteeism due to asthma Fewer than 4 doses per week of a fastacting β2-agonist (apart from one dose/day before exercise) Forced expiratory volume in one second or peak expiratory flow at 90% of personal best or greater Diurnal variability in peak expiratory flow (PEF) of less than 10-15%. This figure is obtained using the following calculation: The checklist above can be used with patients to determine if their asthma is controlled. Alternatively, the 30-second asthma test has been developed to help patients quickly determine if their asthma is controlled. 6 THE ASTHMA LANDSCAPE IN CANADA - AN OVERVIEW Asthma affects over 2 million Canadians (approximately 6.4% of adults older than 12 years of age). 7 It is the most prevalent chronic disease of children in industrialized countries and the most frequently occurring childhood illness after the common cold. 7 Prevalence of asthma and associated morbidity and mortality in industrialized countries has increased dramatically over the past few decades. 8 It is apparent that along with genetic influences, the environment plays a major role in inducing and maintaining the asthma condition. 8 In Canada, approximately 20 children and 500 adults die each year from asthma. It is estimated that more than 80% of asthma-related deaths could be prevented with proper asthma education. 7 It has been estimated that costs in Canada associated with hospitalizations, unscheduled physician visits, emergency department visits, drug treatments and ambulance services associated with uncontrolled asthma are approximately $162 million (US) per year. 10 FIGURE 1: The 30-second asthma test 6 I use my blue inhaler (reliever medication) 4 or more times a week (except one dose/day for exercise). I cough, wheeze or have a tight chest because of my asthma (4 or more days per week). Coughing, wheezing or chest tightness wakes me at night (1 or more times a week). I stop exercising because of my asthma (in the past 3 months). I miss work or school because of my asthma (in the past 3 months). If you checked even one box, your asthma could be dangerously out of control. Don t become a statistic. Act now. See your doctor to find out how to improve your asthma control. Kyle: Part 2 One month later, Kyle returns to the pharmacy for another refill on his salbutamol prescription. After participating in a current asthma education lesson you decide it is time to try and help Kyle understand his condition better and improve his asthma control. His medication history tells you that he has not renewed his budesonide 200 µg prescription for 65 days. Pharmacist: Kyle, how have your asthma symptoms been lately? Kyle: About the same as usual. I use the blue inhaler whenever I feel the need. Pharmacist: Do you have any allergies or sensitivities that bring on your asthma? Kyle: Well, I do have hayfever, but that won t bother me for a while. Pharmacist: How often do you use your controller inhaler? Kyle: You mean the brown one? Pharmacist: Yes, that s the one. Kyle: Well, I only use that when the blue one doesn t last as long. Pharmacist: It s probably been a while since we ve talked about your medications and how they work. After an explanation of the benefits of using the controller medication on a regular basis, and observing Kyle using his inhalers correctly, he agrees that he will try using his budesonide inhaler on a regular basis. He will use it first thing in the morning and as he is getting ready for bed at night. Surveys have suggested that patients with asthma have low expectations of asthma symptom control and readily accept levels of 2 Single-Inhaler Maintenance AND Reliever Therapy for Asthma Control: A Primer for Pharmacists Answer online at October 2006

3 asthma control that are below the standards set by the current Canadian Asthma Consensus Guidelines. 10 Furthermore, many patients accept symptoms such as wheezing, coughing, shortness of breath, missing work due to asthma or experiencing episodes that interfere with sleep or activity as inevitable due to their disease. 10 In a recent survey of patients with asthma, 45% believed that one or two emergency visits were a routine part of having asthma. 11 Studies have also found that many patients do not understand the purpose of their medications. Many patients think that the maintenance medication is used only to treat asthma symptoms after they occur, instead of preventing them from occurring in the first place. 10 A survey conducted in Canada found that 30-40% of ICS users and 20-23% of ICS/LABA users used their maintenance therapy only when experiencing asthma symptoms. 12 Similarly, an Australian study found that 45% of adult patients who had been prescribed an ICS or non-steroidal anti-inflammatory drug reported that they did not consistently use their maintenance medication according to doctor s instructions. 13 Another study found that patients with mild to moderate asthma didn t understand they had a chronic disease, preferring to deal with their asthma only when symptoms became acute. 14 Reasons for patients compromising on the level of asthma control available have been suggested by Canadian psychologists: 10 Disease misconceptions Anxiety about the disease or treatments Misunderstanding of the role of medications False expectations The hurdles associated with managing a chronic disease Poor physician/patient communication Lack of education or understanding about the disease. Through open communication that addresses the issues identified above, pharmacists can play an important role in helping patients understand that better asthma control is achievable. DEFINING ASTHMA SEVERITY Assessment of asthma severity is based on the treatment required to obtain control of asthma as defined by the Canadian Asthma Consensus Recommendations presented earlier. 5 Kyle: Part 3 Kyle returns to your pharmacy 4 weeks after his previous visit for a refill of his budesonide inhaler. In reviewing the Canadian Asthma Consensus guidelines you note that it is difficult to assess Kyle s level of asthma severity (i.e., TABLE 1: Asthma severity as defined by current Canadian guidelines (based on treatment requirements) 5 Asthma severity Symptoms Treatment required to maintain control Very mild Mild-infrequent None, or inhaled short-acting β2-agonist rarely Mild Well-controlled Short-acting β2-agonist (occasionally) and lowdose inhaled corticosteroid Moderate Well-controlled Short-acting β2-agonist and low to moderate doses of inhaled corticosteroid with or without additional therapy. Severe Well-controlled Short-acting β2-agonist and high doses of inhaled corticosteroid and additional therapy (in same order as presented in moderate ). Very severe May be controlled or Short-acting β2-agonist and high doses of inhaled not well-controlled corticosteroid and additional therapy and oral corticosteroid. use criteria outlined in Table 1), because his asthma has never been well-controlled. Pharmacist: Hi Kyle, how are you doing today? Kyle: I m doing a lot better. I m really glad we had that talk about my asthma. I haven t missed one dose of my brown inhaler, and I have only had to use my blue inhaler about once or twice a day. Pharmacist: That s great Kyle. With even better asthma control we could get your blue inhaler use down to a few times a week. It might involve either adding another medication or using an inhaler that contains 2 medications instead of the one in your brown inhaler. Kyle: Please don t add another inhaler! I have enough trouble with two. Pharmacist: Perhaps you could make an appointment with Dr. Jones to discuss the matter? In the meantime would you like me to call her with a recommendation? Kyle: Sure, that would be fine. I think she works one Saturday a month. I ll ask if she can see me then. TREATMENT GOALS FOR ASTHMA MANAGEMENT The treatment goals for asthma defined by the Global Initiative for Asthma/National Institute of Health (GINA) guidelines are as follows: 4 Achieve and maintain control of symptoms Prevent asthma exacerbations Maintain pulmonary function as close to normal levels as possible Maintain normal activity levels, including exercise Avoid adverse effects from asthma medications Prevent development of irreversible airflow limitation Prevent asthma mortality THE CONTINUUM OF ASTHMA MANAGEMENT The Canadian Asthma Consensus Guidelines recommend a continuum of asthma management as follows: 1 Attention should always be paid to environmental control (i.e., identifying asthma triggers and avoiding/preventing exposure). Assessment of asthma control, triggers, compliance with treatment regimens, inhaler technique and co-morbidities should take place on a regular basis. Very mild asthma: short-acting β2-agonists, taken as needed. Mild asthma: introduce ICS at low dose (see Table 2). For those who cannot or will not use ICS, leukotriene receptor antagonists are an alternative, although less effective than low-dose ICS. Moderate to moderately-severe asthma: If asthma not adequately controlled by ICS, add LABA. Alternatives, but less effective options are to add LTRA or increase ICS to a moderate dose. Theophylline is a third therapeutic option. Severe asthma may require additional treatment with oral prednisone. All alterations in medication therapy should be considered a trial, and effectiveness should be re-evaluated after a reasonable period of time. After optimal asthma control is achieved, medications should be reduced to the minimum necessary to maintain control. COMPLEMENTARY ASTHMA MANAGEMENT ACTIVITY OF ICS AND LABA: SCIENTIFIC RATIONALE The improved effectiveness of adding a LABA to ICS over higher doses of ICS alone in patients with persistent asthma of different severities has been demonstrated in numerous clinical trials These outcomes can be explained by considering the following rationale: 18,19 October 2006 Answer online at Single-Inhaler Maintenance AND Reliever Therapy for Asthma Control: A Primer for Pharmacists 3

4 FIGURE 2: Continuum of Asthma Management: Canadian Consensus Guidelines Update possibly by priming the glucocorticoid receptor for activation. 18 LABAs are also thought to protect against mast cell mediator release and reduce plasma exudation 19 Continuum of asthma management. Very mild asthma is treated with short-acting β2-agonists, taken as needed. Inhaled corticosteroids (ICSs) may be introduced as the initial maintenance treatment for asthma, even in subjects who report asthma symptoms less than three times per week. For patients who cannot or will not use ICSs, leukotriene receptor antagonists are an alternative, although they are less effective than low doses of ICSs. If asthma is not adequately controlled by low doses of ICSs, additional therapy should be considered. Addition of long-acting β2-agonists should be considered as the first option. As an alternative, addition of leukotriene receptor antagonists or increasing ICSs to a moderate dose of may be considered. Theophylline may be considered as a third therapeutic option. Severe asthma may require additional treatment with prednisone (Pred).Asthma control should be assessed at each visit, and maintenance therapy should be altered if necessary. Any alteration in medication therapy should be considered a trial, and effectiveness should be re-evaluated after a reasonable period of time. After achieving full control, the medication should be reduced to the minimum necessary to maintain control TABLE 2: Dose equivalencies for inhaled corticosteroids 1 Product Low Dose Medium Dose High Dose (µg/day) (µg/day) (µg/day) Beclomethasone dipropionate pmdi* + spacer >1000 Budesonide Turbuhaler >800 Fluticasone propionate pmdi + spacer >500 Fluticasone propionate Diskus >500 Beclomethasone dipropionate pmdi (HFA) QVAR >500 Budesonide wet nebulization >2000 Evidence clearly shows that ICS are more potent and effective in controlling airway inflammation than any other long-term controllers. Similarly, LABA have been shown to reverse bronchoconstriction more effectively than the shortacting β2-agonists, theophylline and LTRA. The 2 classes of drugs have complementary mechanisms of action if one considers a model of the components of asthma as illustrated in Figure 2. Corticosteroids prevent the formation of prostaglandins and leukotrienes from arachadonic acid. 18 They also modulate the action of many inter- and intracellular mediators and influence the transcription of target genes that regulate the production of cytokines, receptors and enzymes. LABAs bind to β2-adrenoreceptors, thereby stimulating the production of cyclic adenosine 3,5 -monophosphate and causing relaxation of bronchial smooth muscle and inhibition of the release of pro-inflammatory mediators from mast cells. 18 Besides their complementary mechanisms of action, evidence suggests that ICS improves the effectiveness of LABA by up-regulation of β2 receptors, and LABA improve the effectiveness of ICS, *Budesonide/formoterol has not yet received approval for the SMART indication in Canada. Kyle: Part 4 You are pleased that Kyle has started using his ICS therapy on a regular basis and that he is doing much better. However, you realize that he is still not optimally managed as he continues to need his reliever therapy once or twice a day. You realize that the next step in therapy is the addition of a LABA. You remember reading an article in a recent pharmacy journal about the use of combination budesonide and formoterol for both maintenance and relief of asthma. You recall that the frequency of severe exacerbations was reduced with this combination versus LABA and ICS as maintenance with a short-acting β2-agonist as reliever. Upon further research you find an announcement that this management protocol is now indicated for the management and relief of asthma and decide to discuss this with Dr. Jones as an excellent option for Kyle * BUDESONIDE/FORMOTEROL AS SINGLE-INHALER MAINTENANCE AND RELIEVER THERAPY A LOOK AT THE EVIDENCE Formoterol for asthma relief As effective as short-acting β2-agonists? In order to accept the concept of using one inhaler for both maintenance and relief, one must appreciate the effectiveness of formoterol and formoterol/budesonide for asthma relief. Formoterol has been shown to have an onset of action as fast as salbutamol, 1-3 minutes after inhalation. 20 In a study of 362 patients using maintenance doses of ICS and randomized to use terbutaline 0.5 mg or formoterol 4.5 µg (delivered) as needed by turbuhaler, those using formoterol required fewer inhalations of rescue medication and had a longer time before the first severe exacerbation of asthma compared with those using terbutaline. 21 Although beneficial bronchodilator effects of formoterol were longer-lasting than terbutaline, no safety issues were identified and the number and pattern of events (including duration of adverse events) were similar in the 2 groups. 21 Budesonide/formoterol in combination has also been shown in a clinical trial to be as effective and well-tolerated as salbutamol in relieving acute asthma. 22 It is extremely important to note that formoterol is a full β2-agonist whereas salmeterol is a partial β2-agonist and has a slower onset of action that does not pro- 4 Single-Inhaler Maintenance AND Reliever Therapy for Asthma Control: A Primer for Pharmacists Answer online at October 2006

5 FIGURE 3: Pathophysiological mechanisms of asthma symptoms 18 symptoms. 3,32-34 Results suggest that the improved efficacy of the single-inhaler approach is associated more with the timing of the increase in ICS dose (resulting from budesonide/ formoterol as prn medication) representing early intervention, than with the total ICS dose. 3 Results suggest that both the early increase in ICS dose and the long-acting effects of formoterol compared with a short-acting β2-agonist play a role in the positive results reported in each of the studies cited in Table 3. 3 A recent cost-effective analysis of the single-inhaler budesonide/formoterol approach versus using combination ICS/LABA (fluticasone/salmeterol) regularly plus salbutamol prn in over 2,000 European patients found that the single inhaler approach reduced the number of severe asthma exacerbations per patient per year at no significantly increased cost, or at lower cost compared to the alternative therapy. 35 vide adequate asthma relief for acute symptoms. 23,24 Therefore, salmeterol must never be used as a rescue medication. 24 LABA safety issues - Recent concerns In October 2005, Health Canada released an advisory about safety of LABA therapy as a result of the release of results of the Salmeterol Multi-Center Asthma Research Trial. 25 The study of approximately 30,000 patients was discontinued when an interim analysis suggested a small but statistically significant increased risk of asthma-related death in patients using salmeterol compared to placebo (13 of 13,176 patients vs. 3 of 13,179 patients). 26 Evidence suggests that risks may be higher in African- American patients and in those patients who were not treated with ICS at the start of the study. 26 Prescribing information for salmeterol-containing products has been updated. See media/advisories-avis/2005/2005_107_e.html for details. Health Canada states in its warning that it is unknown whether the concerns associated with salmeterol also apply to formoterol. Formoterol has been studied extensively in clinical trials involving over 28,000 patients and has been used for more than 2.7 million treatment years since release of the medication. Over this time period, the risks noted have not been evident with formoterol use. 27 Health Canada asks that any cases of serious respiratory-related or other serious or unexpected adverse reactions in patients taking salmeterol or formoterol products be reported to their Adverse Drug Reaction Monitoring Program at 25 BUDESONIDE/FORMOTEROL AS SINGLE-INHALER MAINTENANCE AND RELIEVER THERAPY A LOOK AT THE EVIDENCE Periodic fluctuations in symptoms and airway inflammation are common in asthma. Therefore reliever use can vary over time. The accepted approach to dealing with the variability in need for asthma relief has been to add a LABA to ICS in a combination ICS/LABA dosage form (i.e., budesonide/formoterol or fluticasone/salmeterol) and use routinely twice a day. In this protocol, a short-acting β2-agonist must always be available for asthma relief. Evidence from a large controlled trial suggests that asthma exacerbations evolve slowly over a few days with a fall in PEF and increased symptoms and reliever medication use. 28 This knowledge, along with emerging evidence that ICS begins reducing airway inflammation much more rapidly (as early as 6 hours) than previously thought, led to the hypothesis that as needed use of both ICS and formoterol (instead of a short-acting β2- agonist alone) would reduce the frequency of asthma exacerbations. 29,30 Studies were developed to determine if this immediate intervention with a one-inhaler approach (i.e., budesonide/formoterol) could nip worsening asthma in the bud. 31 See Table 3 for a review of clinical trial program assessing this strategy. Results of all 4 studies cited in Table 3 suggest that budesonide/formoterol as single-inhaler therapy for both maintenance and relief of asthma is more effective for lengthening time to first severe exacerbation, reducing number, reducing severe exacerbation rate and improving asthma How does this treatment paradigm shift affect patient care and pharmacist intervention? The benefits of using a single inhaler containing budesonide and formoterol for both maintenance and relief in treating asthma have caused a paradigm shift in asthma patient care. With this protocol, patients will no longer require an extra inhaler for relief. This may have implications for treatment adherence in addition to the clinical benefits documented in the studies cited in Table 3. Kyle: Part 5 Kyle enters the pharmacy with a prescription for budesonide/formoterol 200/6 µg, inhaler. Use 2 inhalations twice a day + prn. Kyle: Thanks so much for calling Dr. Jones. She really appreciated your call and thought this would be a great treatment for me to try. I m really happy that I only have to carry around one inhaler! Pharmacist: I m happy to hear you think this is a good idea. I want to assure you that studies have shown that an inhalation of this combination of ingredients is just as effective for relieving occasional asthma symptoms as your blue one was. In fact, the studies show you will likely need to use the inhaler for relief purposes less often than your blue inhaler. Kyle: That s great. I didn t like being so dependent on that inhaler. Pharmacist: I just want to remind you that it is still very important that you use this inhaler regularly twice a day, just as you were using your budesonide. It s great that you got into a routine with that. Kyle: Yes, I could see the difference in my breathing once I started using it regularly. The October 2006 Answer online at Single-Inhaler Maintenance AND Reliever Therapy for Asthma Control: A Primer for Pharmacists 5

6 TABLE 3: Overview of clinical trials assessing efficacy of single-inhaler maintenance and reliever asthma therapy vs. traditional protocols Study and Methods Study Outcomes Comments O'Byrne et al. 3 (randomized double-blind study) Primary outcome of time to first severe asthma Mean daily dose of budesonide used in 2,760 patients with asthma aged 4-80 exacerbation significantly prolonged with maintenance and relief group was 240 µg/day years, followed for one year budesonide/formoterol for maintenance and in adults and 126 µg/day in children Patients randomized to: relief (p<0.001) resulting in 45-47% lower compared with 640 µg/day in adults and Terbutaline 0.4 mg as reliever with: exacerbation risk versus budesonide/formoterol 320 µg/day in children for high-dose budesonide/formoterol 80/4.5 µg bid, or + SABA or budesonide high-dose maintenance budesonide plus terbutaline group. Terbutaline 0.4 mg as reliever with plus terbutaline reliever. No notable differences in 3 groups for budesonide 320 µg bid as maintenance, or Budesonide/formoterol as maintenance and adverse events. Serious adverse events Budesonide/formoterol 80/4.5 µg bid as reliever also prolonged time to first, second and occurred in 5-7% in the 3 groups. maintenance and prn as reliever third exacerbation requiring medical intervention Children in both budesonide/formoterol Children (aged 4-11 years) used once- (p<0.001), reduced severe exacerbation rate, groups grew significantly more than those nightly maintenance doses instead of twice and improved symptoms, awakenings, and lung in high-dose budesonide group. daily (i.e., half of the adult dosage). function compared with both fixed dosing regimens. Rabe et al. 32 (randomized double-blind study) Primary outcome of morning peak expiratory 77% fewer oral steroid treatment days 697 patients, aged years, with mild flow (PEF) significantly improved in budesonide/ (114 days vs. 498 days) with budesonide/ to moderate asthma followed for 6 months. formoterol as maintenance and reliever group vs. formoterol maintenance and reliever vs. Patients randomized to: double budesonide group L/min vs. double dose budesonide protocol. Budesonide/formoterol 80/4.5 µg, 2 inhala- 9.5 L/min. (p<0.001). Adverse events and serious adverse events tions once daily for maintenance and prn for Risk of severe exacerbation 54% lower and were similar in incidence, frequency and type symptom relief, or Budesonide 160 µg, hospitalizations/emergency department treatments in both groups. 2 inhalations once daily for maintenance 90% fewer with budesonide/formoterol mainteplus terbutaline 0.4 mg prn for symptom relief. nance and reliever vs. double budesonide protocol. Schicchitano et al. 33 Time to first severe exacerbation significantly Patients using budesonide/formoterol (randomized double-blind study) prolonged in budesonide/formoterol maintenance maintenance and reliever single-inhaler 1,890 patients with moderate to severe and reliever inhaler therapy vs.double budesonide therapy had lower mean daily dose of ICS asthma followed for 12 months plus terbutaline protocol. (p<0.001) (466 µg,/day vs. 640 µg,/day) and needed Patients randomized to: Risk of severe exacerbation 39% lower with 44% fewer treatment days with systemic Budesonide/formoterol 160/4.5 µg, budesonide/formoterol maintenance and reliever steroids compared with patients using 2 inhalations once daily for maintenance inhaler therapy compared with budesonide plus budesonide plus terbutaline. and prn for symptom relief, or Budesonide terbutaline. (p< 0.001) Incidence, frequency and profile of adverse 160 µg, 2 inhalations twice daily for Budesonide/formoterol maintenance and events and serious adverse events were maintenance plus terbutaline 0.4 mg prn reliever inhaler also resulted in fewer hospitali- similar between 2 treatment groups. for symptom relief. zations/emergency room treatments, fewer treatment days with systemic steroids and patients required less medication overall. Vogelmeier et al. 34 (randomized open study) Budesonide/ formoterol single-inhaler mainte- Mean ICS dose during treatment similar in 2,143 adolescents and adults with nance and reliever therapy prolonged time to first both groups. asthma followed for 12 months. severe exacerbation vs. salmeterol/fluticasone Both treatments well tolerated and no Patients randomized to: plus salbutamol (25% risk reduction). notable differences between groups in Budesonide/formoterol 160/4.5 µg, bid Budesonide/formoterol group required less as- number or severity of adverse or serious plus as needed, or salmeterol/fluticasone needed inhalations (0.58 vs inhalations/day). events. 50/250 µg, bid plus salbutamol as needed. After 4 weeks physicians were free to titrate maintenance dose as per normal practice. Note: Budesonide 80 µg (delivered dose - terminology used in studies) = Budesonide 100 µg metered dose (Canadian dosage form); Budesonide 160 µg (delivered dose - terminology used in studies) = Budesonide 200 µg metered dose (Canadian dosage form); Budesonide 320 µg (delivered dose - terminology used in studies) = Budesonide 400 µg metered dose (Canadian dosage form); Formoterol 4.5 µg (delivered dose) = Formoterol 6 µg metered dose (Canadian dosage form) possibility that my breathing might improve even more seems almost too good to be true! In counselling patients about using budesonide/formoterol as a single inhaler for maintenance and relief of asthma, the following points are critical: Patients must be advised that maintenance doses (i.e. twice daily) of the budesonide/formoterol inhaler are still necessary. The difference from previous protocols lies in using the same inhaler as a reliever therapy instead of a separate short-acting β2-agonist such as salbutamol or terbutaline. Patients must be assured that the relief benefits derived from the combination inhaler have been proven as effective in the short-term as short-acting β2-agonists, and more beneficial in the long-term. Maximum dosing: Patients should be reminded that 8 total inhalations is the maximum that should be used in a day without contacting their physician. 36 Some patients may be worried about using too much corticosteroid when using it for prn as well as maintenance medication. Patients should be reassured up-front that studies even with maximum recommended doses (which is seldom required) result in less corticosteroid exposure with budesonide than traditional protocols. This protocol does not represent a method of treating severe exacerbations and in no way changes the need for development of Action Plans designed to guide patients through actions to take when faced with an exacerbation. SUMMARY: SINGLE-INHALER (BUDESONIDE/FORMOTEROL) MAINTENANCE AND RELIEVER THERAPY Budesonide/formoterol used for both maintenance and relief of asthma has been found in clinical trials to provide superior control compared to both a 4-fold higher dose of budesonide with short-acting β2-agonist or budesonide/ formoterol maintenance with short-acting 6 Single-Inhaler Maintenance AND Reliever Therapy for Asthma Control: A Primer for Pharmacists Answer online at October 2006

7 β2-agonist, resulting in: - Fewer exacerbations of all types - Less as-needed medication - Fewer nocturnal awakenings - Greater improvement in lung function - Greater improvement in quality of life In addition, improved control was achieved with: - Lower overall daily dose of ICS vs. 4-fold budesonide plus short-acting β2-agonist - Lower exposure to systemic steroids compared to both budesonide plus short-acting β2-agonist and budesonide/formoterol plus short-acting β2-agonist The single-inhaler maintenance and reliever therapy was generally well-tolerated. The use of budesonide/formoterol as single-inhaler maintenance and reliever asthma therapy represents a paradigm shift for both patients and health professionals. Pharmacists must play a critical role in helping all individuals understand and correctly apply the principles of this novel approach to therapy. The outcome of such activity is improved quality of life for patients with asthma through improved control of their condition. REFERENCES 1. Lemiere C, Bai T, Balter M, Bayliff C, Becker A, Boulet LP et al. Adult Asthma Consensus Guidelines Update Can Respir J 2004; 11(Suppl A):9A-18A. 2. Joyce DP, McIvor RA. Use of inhaled medications and urgent care services. Study of Canadian asthma patients. Can Fam Physician 1999; 45: O Byrne PM, Bisgaard H, Godard PP, Pistolesi M, Palmqvist M, Zhu Y et al. Budesonide/formoterol combination therapy as both maintenance and reliever medication in asthma. Am J Respir Crit Care Med 2005; 171(2): Global Initiative for Asthma. A pocket guide for asthma management and prevention; Updated Global Strategy for Asthma Managment and Prevention (Updated 2003) NIHG Publication No Boulet LP, Becker A, Berube D, Beveridge R, Ernst P. Canadian Asthma Consensus Report, CMAJ 1999; 161 ((11 Suppl)):S1-S Asthma in Canada.The 30 second asthma test.available online at asthmaincanada.com. Accessed March 27, BC Lung Association. Asthma in Canada: Challenges in determining the scope of asthma. Available online at worldasthma/canadianpicture.htm. Accessed March 27, Manfreda J, Becklake MR, Sears MR, Chan-Yeung M, Dimich- Ward H, Siersted HC et al. Prevalence of asthma symptoms among adults aged years in Canada. CMAJ 2001; 164(7): Seung SJ, Mittmann N. Urgent care costs of uncontrolled asthma in Canada, Can Respir J 2005; 12(8): Aboussafy D. The Psychology of Compromise: A focus on Asthma. The Lung Association Available online at include/pdf/nouvelle/pdcen.pdf. Accessed March 27, Chapman KR, Boulet L, Fitzgerald MJ, McIvor R, Zimmerman S. Patient factor associated with suboptimal asthma control in Canada: Results from the Reality of Asthma Control (TRAC) Study. American Thoracic Society, San Diego, May 24, Chapman K, McIvor R, FitzGerald JM, Boulet L, Zimmerman S. Asthma exacerbation self-management: National Landmark Survey Results from the Reality of Asthma Control (TRAC) Study. Presented to American Thoracic Society, SanDiego, California, May 24, Sawyer SM, Fardy HJ. Bridging the gap between doctors and patients expectations of asthma management. J Asthma 2003; 40(2): Jones A, Pill R, Adams S. Qualitative study of views of health professionals and patients on guided self management plans for asthma. BMJ 2000; 321(7275): Pauwels RA, Lofdahl CG, Postma DS,Tattersfield AE, O Byrne P, Barnes PJ et al. Effect of inhaled formoterol and budesonide on exacerbations of asthma. Formoterol and Corticosteroids Establishing Therapy (FACET) International Study Group. N Engl J Med 1997; 337(20): O Byrne PM, Barnes PJ, Rodriguez-Roisin R, Runnerstrom E, Sandstrom T, Svensson K et al. Low dose inhaled budesonide and formoterol in mild persistent asthma: The OPTIMA randomized trial. Am J Respir Crit Care Med 2001; 164(8 Pt 1): Bateman ED, Boushey HA, Bousquet J, Busse WW, Clark TJ, Pauwels RA et al. Can guideline-defined asthma control be achieved? The Gaining Optimal Asthma ControL study. Am J Respir Crit Care Med 2004; 170(8): Stoloff S, Poinsett-Holmes K, Dorinsky PM. Combination therapy with inhaled long-acting beta2-agonists and inhaled corticosteroids: A paradigm shift in asthma management. Pharmacotherapy 2002; 22(2): Barnes PJ. Scientific rationale for inhaled combination therapy with long-acting beta2-agonists and corticosteroids. Eur Respir J 2002; 19(1): Seberova E,Andersson A. Oxis (formoterol given by Turbuhaler) showed as rapid an onset of action as salbutamol given by a pmdi. Respir Med 2000; 94(6): Tattersfield AE, Lofdahl CG, Postma DS, Eivindson A, Schreurs AG, Rasidakis A et al. Comparison of formoterol and terbutaline for asneeded treatment of asthma: A randomised trial. Lancet 2001; 357(9252): Balanag VM, Yunus F, Yang PC, Jorup C. Budesonide/formoterol in a single inhaler is as effective and well tolerated as salbutamol in relieving acute asthma in adults and adolescents. Eur Respir J 2003; 22 (Suppl. 45): 445s. 23. Palmqvist M, Ibsen T, Mellen A, Lotvall J. Comparison of the relative efficacy of formoterol and salmeterol in asthmatic patients. Am J Respir Crit Care Med 1999; 160(1): Serevent Product Monograph. Compendium of Pharmaceuticals and Specialties Health Canada. Advisory: Safety information about a class of asthma drugs known as long-acting beta-2 agoinists. Available online at 107_e.html. Accessed March 27, Nelson HS, Weiss ST, Bleecker ER, Yancey SW, Dorinsky PM. The Salmeterol Multicenter Asthma Research Trial: A comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol. Chest 2006; 129(1): Health Canada Endorsed Update on Drug Safety Information: Updated safety information regarding the US FDA Pulmonary-Allergy Drugs Advisory Committtee (PADAC) meeting to review the safety of the long-acting beta agonists. Available online at documents/en/news/oxeze%20dhcpl% pdf. Accessed May 22, Tattersfield AE, Postma DS, Barnes PJ, Svensson K, Bauer CA, O Byrne PM et al. Exacerbations of asthma: A descriptive study of 425 severe exacerbations. The FACET International Study Group. Am J Respir Crit Care Med 1999; 160(2): Gibson PG, Saltos N, Fakes K.Acute anti-inflammatory effects of inhaled budesonide in asthma: A randomized controlled trial. Am J Respir Crit Care Med 2001; 163(1): Ketchell RI, Jensen MW, Lumley P, Wright AM, Allenby MI, O connor BJ. Rapid effect of inhaled fluticasone propionate on airway responsiveness to adenosine 5 -monophosphate in mild asthma. J Allergy Clin Immunol 2002; 110(4): Barnes PJ. A single inhaler for asthma? Am J Respir Crit Care Med 2005; 171(2): Rabe KF, Pizzichini E, Stallberg B, Romero S, Balanzat AM, Atienza T et al. Budesonide/formoterol in a single inhaler for maintenance and relief in mild-to-moderate asthma: A randomized, doubleblind trial. Chest 2006; 129(2): Scicchitano R, Aalbers R, Ukena D, Manjra A, Fouquert L, Centanni S et al. Efficacy and safety of budesonide/formoterol single inhaler therapy versus a higher dose of budesonide in moderate to severe asthma. Curr Med Res Opin 2004; 20(9): Vogelmeier C, D Urzo A, Pauwels R, Merino JM, Jaspal M, Boutet S et al. Budesonide/formoterol maintenance and reliever therapy: An effective asthma treatment option? Eur Respir J 2005; 26(5): Johansson G, Andreasson EB, Larsson PE, and Vogelmeier CF. Cost effectiveness of budesonide/formoterol for maintenance and reliever therapy versus salmeterol/fluticasone plus salbutamol in the treatment of asthma. Pharmacoeconomics 2006; 24(7): AstraZeneca. Data on file, QUESTIONS CASE #1 Susan is a 27-year-old teacher on maternity leave caring for her young infant. Susan and her husband have recently moved to a larger house in preparation for their changing family life. Susan has had asthma since childhood and currently uses budesonide 100 µg twice daily regularly and salbutamol inhaler prn. She uses an average of one prn dose of salbutamol inhaler daily (not including preexercise doses). 1. Which statement(s) is/are TRUE about asthma? a) Symptoms of asthma are entirely related to airway inflammation. b) Many children with asthma do not have asthma symptoms by the time they reach Susan s age. c) A period of 11 weeks between refills for a short-acting beta-agonist would indicate acceptable asthma control if used once daily pre-exercise. d) b and c 2. What is the estimated percentage of asthma-related deaths that could be prevented with proper asthma education? a) 20% c) 60% b) 40% d) 80% 3. Which statement(s) would lead you to conclude that Susan s asthma is not under control? a) Susan says she wakes up about once a month with asthma symptoms. b) Susan uses her reliever medication once daily. c) Susan says if she stops using her budesonide inhaler she gets more frequent symptoms. d) a and b 4. Which difference in Peak Expiratory Flow between daytime and nighttime readings would indicate that asthma may not be controlled? a) 30% or more b) 20% or more c) 10% or more d) 5% or more 5. Susan tells you that her asthma is well controlled despite answering yes to 2 of the 30-second asthma test questions. Which statement(s) is/are TRUE? a) Almost half of patients surveyed believed that one or two asthma-related emergency visits were a routine part of having asthma. b) According to a Canadian survey, less than 10% of people with asthma use their ICS only when symptoms worsen. c) Surveys suggest that about 20% of asthma patients are nonadherent with October 2006 Answer online at Single-Inhaler Maintenance AND Reliever Therapy for Asthma Control: A Primer for Pharmacists 7

8 QUESTIONS continued medication regimens. d) None of the statements are correct. e) All of the statements are correct. 6. What level of ICS is Susan currently using for asthma management? a) Low dose b) Medium dose c) Medium to high dose d) High dose 7. If Susan s asthma were controlled with her current medication regimen, what severity of asthma would she be classified as having? a) Very mild b) Mild to moderate c) Moderate to severe d) Severe 8. According to the Canadian Asthma Consensus Guidelines, which medication changes would be most appropriate for Susan? a) Double her dose of budesonide. b) Use a more potent ICS c) Add a LABA d) Add a leukotriene-receptor antagonist CASE #2 Frank is a 45-year-old male who continues to require twice-daily doses of terbutaline inhaler despite regular twice-daily use of budesonide/formoterol 100/6 µg. His doctor calls and asks about new information he has heard with respect to using formoterol as a reliever. 9. Which statement(s) regarding formoterol as a reliever medication is/are TRUE? a) Formoterol has been shown in clinical trial to have as fast an onset of bronchodilation as salbutamol. b) Formoterol has longer lasting bronchodilating effects than salbutamol. c) Formoterol s adverse effects last longer than terbutaline. d) a and b e) All answers are true. 10. Which statement(s) regarding formoterol and salmeterol is/are TRUE? a) Salmeterol was found in a large study to be associated with a small but significantly increased risk of asthma-related death compared with placebo. b) Salmeterol and formoterol are both partial beta-agonists c) African-American patients may be at increased risk for adverse effects associated with LABA. d) a and b e) a and c 11. Frank s doctor asks why using combination budesonide/formoterol would be any better than just using formoterol for relief? Which answer(s) is/are most appropriate? a) Although budesonide doesn t add any overall value, it is easier to use just one inhaler. b) Using ICS early in exacerbation onset can help prevent severe exacerbation. c) When using combination therapy, one doesn t necessarily require the maintenance doses. d) a and b e) b and c 12. Which statement about ICS and LABA is FALSE? a) LABAs cause relaxation of bronchial smooth muscle b) ICS up-regulates β2 adrenoreceptors c) LABAs promote release of proinflammatory mediators from mast cells. d) ICS prevent formation of leukotrienes and prostaglandins. 13. What reverses bronchoconstriction at least as well as LABA? a) Leukotriene-receptor antagonists b) Short-acting β2-agonists c) Theophylline d) None of the above 14. Frank s doctor calls two weeks later and asks you if there is any evidence that budesonide/formoterol as a single inhaler is more effective for reducing asthmarelated nocturnal awakenings than other protocols? What is the correct response? a) There isn t direct evidence, but one can assume that would be so. b) Yes, there is good quality study evidence compared to either quadruple budesonide dose plus terbutaline and budesonide/formoterol plus terbutaline. c) Evidence actually suggests no difference in nocturnal awakenings compared to 4- times budesonide dose plus short-acting β2-agonist d) Evidence actually suggests no difference in nocturnal awakenings compared to budesonide/formoterol plus terbutaline as reliever. 15. Frank has an 18-year-old son who he thinks could benefit from single-inhaler maintenance and reliever therapy. Which of the following counseling statements is FALSE? a) Budesonide/formoterol as reliever has been shown to afford longer intervals between need for using asthma relief medication than salbutamol used as reliever. b) People using budesonide/formoterol as maintenance and reliever will require on average two extra doses of reliever weekly. c) People using budesonide/formoterol as maintenance and reliever will likely require less reliever medication than those using ICS for maintenance plus short-acting β2-agonist as reliever. 16. Which of the following mechanisms are thought to play a significant role in the effectiveness of budesonide/formoterol maintenance and reliever therapy in prolonging time to first asthma exacerbation? a) Timing of early increase in ICS dose b) Use of increased number of inhalations daily. c) Long-lasting effects of formoterol vs short-acting β2-agonists d) a and c 17. Frank s doctor asks you if adverse effects are a concern when using the budesonide/formoterol single-inhaler maintenance and reliever therapy. What is the most appropriate response? a) There were no significant differences in adverse events among treatments used. b) The single-inhaler therapy was associated with increased severe adverse effects. c) The high-dose budesonide therapy was associated with increased severe adverse effects. d) The budesonide/formoterol plus terbutaline therapy was associated with increased severe adverse effects. 18. What represents high-dose ICS therapy? a) Fluticasone 250 µg, 2 inhalations twice daily b) Budesonide 200 µg, one inhalation bid c) Budesonide wet nebulization 250 µg qid d) All of the above 19. Frank enters your pharmacy the next week with a prescription for budesonide/formoterol 100/6 µg bid and prn. Frank asks you how many total inhalations he can have during the day. What is the correct answer? a) 2 c) 6 b) 4 d) If Frank s asthma were eventually controlled with budesonide/formoterol 200/6 µg, 2 inhalations twice daily, at what level of severity would his asthma be classified? a) Mild c) Severe b) Moderate d) Very Severe 8 Single-Inhaler Maintenance AND Reliever Therapy for Asthma Control: A Primer for Pharmacists Answer online at October 2006

9 TO ANSWER THIS CE LESSON ONLINE If currently logged into our ONLINE CE PROGRAM, please return to the "Lessons Available Online" Page and click on "Link to questions" for this CE Lesson. If not logged in but already registered to our ONLINE CE PROGRAM, please click here: If you have not registered for our ONLINE CE PROGRAM and wish to answer online, please click here: If you have any questions. Please contact: Pharmacy Practice, Pharmacy Post, Novopharm CE Compliance Centre, More CCCEP-approved CE s, or Tech Talk (English and French CE's) Mayra Ramos Fax: (416) or Quebec Pharmacie and L'actualite Pharmaceutique Stephane Paradis Fax: (514)

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